Quality Control and Safety Evaluation of Culture Medium for Human Assisted Reproduction.
10.3969/j.issn.1671-7104.2021.06.003
- Author:
Danmei ZHAO
1
;
Yuanli HUANG
1
;
Chunren WANG
1
;
Linnan KE
1
;
Qianqian HAN
1
Author Information
1. National Institutes for Food and Drug Control, Beijing, 102629.
- Publication Type:Journal Article
- Keywords:
added drugs;
component stability;
culture medium for human assisted reproduction;
degradation products and impurities;
quality control
- MeSH:
Humans;
Quality Control;
Reproduction;
Reproductive Techniques, Assisted
- From:Chinese Journal of Medical Instrumentation
2021;45(6):599-603
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:In this paper, the key points of quality control and safety evaluation of human assisted reproductive medium were summarized to provide reference for the establishment of relevant standards and quality control in the future.
METHODS:Through literature research, the key factors of quality control and risk control of human assisted reproductive medium were summarized, and the problems in clinical transformation were discussed.
RESULTS:It is very important for the development of human assisted reproduction technology to study the active ingredients and their harmful degradation products and drugs in the culture medium of assisted reproduction.
CONCLUSIONS:At present, the biggest challenge is to effectively control the quality of the culture medium for human assisted reproduction, establish corresponding inspection methods and quality standards for the key components, ensure the safety and effectiveness during the product shelf life, and thus improve the success rate of human assisted reproduction technology.
